A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Rheumatoid Arthritis

Inclusion criteria

• Provide signed informed consent.
• RA diagnosis consistent with the 2010 ACR/EULAR criteria;
• Moderate to severe RA defined by 6 or more tender joints, 6 or more swollen joints (68- or 66-joint count), and an ESR of 28 mm/h or greater or a CRP level greater than 5mg/L.
• Subjects were required to have an inadequate response to treatment with csDMARDs before baseline.
• If subjects are taking permitted csDMARDs or low-dose corticosteroid orally at baseline , the stable doses should have lasted for more than 4 weeks already.
• BMI ≥18 kg/m2

Exclusion criteria

• Pregnant women or refuse to receive contraception during the study.
• Lab abnormality within 4 weeks of randomization as follows: WBC count <3.0×10^9/L；neutrophil count<1.5×10^9/L;hemoglobin level<90.0 g/L ; platelet count <100×10^9/L; AST or ALT levels greater than the upper limit of normal; HBsAg or HCV or HIV antibody positivity.
• History of another autoimmune rheumatic disease ; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases.
• Previous treatment with JAK inhibitor or cytotoxic drugs; bDMARDs within 6 months of randomization; other strong immunosuppressants within 3 months of randomization.